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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05687903
Registration number
NCT05687903
Ethics application status
Date submitted
9/01/2023
Date registered
18/01/2023
Date last updated
9/01/2025
Titles & IDs
Public title
A Study of TAK-861 in Participants With Narcolepsy Type 1
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Scientific title
A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-861 for the Treatment of Narcolepsy With Cataplexy (Narcolepsy Type 1)
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Secondary ID [1]
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2022-001654-38
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Secondary ID [2]
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TAK-861-2001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Narcolepsy Type 1
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Condition category
Condition code
Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - TAK-861
Treatment: Drugs - Placebo
Placebo comparator: Placebo - Participants received placebo tablets matching TAK-861, orally, twice daily (BID), from Days 1 to 56.
Experimental: TAK-861 0.5 mg BID - Participants received TAK-861 0.5 milligrams (mg), orally, BID, from Days 1 to 56.
Experimental: TAK-861 2 mg BID - Participants received TAK-861 2 mg, orally, BID, from Days 1 to 56.
Experimental: TAK-861 2 mg and 5 mg - Participants received TAK-861 2 mg followed by 5 mg dose, orally, BID, from Days 1 to 56.
Experimental: TAK-861 7 mg QD - Participants received TAK-861 7 mg, orally, once daily (QD), from Day 1 to 56. Placebo was given as the second dose.
Treatment: Drugs: TAK-861
TAK-861 oral tablets
Treatment: Drugs: Placebo
Placebo oral tablets matching TAK-861
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in the Average Sleep Latency as Determined From the MWT at Week 8
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Assessment method [1]
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The MWT is a validated, objective measure that evaluates a participant's ability to remain awake under soporific conditions for a defined period. During each MWT session (1 session = 40 minutes), participants were instructed to sit quietly and remain awake for as long as possible. Sleep latency in each session was recorded on EEG. If no sleep was observed according to these rules, then the latency was defined as 40 minutes. The linear mixed effects model for repeated measures (MMRM) was used for analysis.
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Timepoint [1]
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Baseline, Week 8
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Secondary outcome [1]
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Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 8
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Assessment method [1]
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The ESS is a subjective, self-administered, validated scale (scored 0 to 3) to respond to each of the 8 questions of daily life that asks participants how likely they are to fall asleep in those situations. The scores are summed to give an overall score of 0 to 24. Higher scores indicate stronger subjective daytime sleepiness, and scores below 10 are considered to be within the normal range. The MMRM was used for analysis.
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Timepoint [1]
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Baseline, Week 8
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Secondary outcome [2]
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Weekly Cataplexy Rate (WCR) at Week 8
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Assessment method [2]
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Participants completed a daily patient-reported sleep diary to record self-reported narcolepsy symptoms. Participants recorded episodes of cataplexy attacks in the diary. The total number of events averaged for a week were reported. WCR = (total number of cataplexy attacks over a number of non-missing diary days for a given duration/number of non-missing diary days in that duration)\*7. The generalized estimating equations (GEE) model was used for analysis.
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Timepoint [2]
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Week 8
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Secondary outcome [3]
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Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
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Assessment method [3]
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An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not the occurrence was considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an AE with an onset that occurred after receiving study drug.
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Timepoint [3]
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From first dose of the study drug up to end of the study (up to 3 months)
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Eligibility
Key inclusion criteria
1. The participant is aged 18 to 70 years, inclusive, at the time of signing the informed consent form (ICF).
Note: In Japan, participants aged 16 to 70 years, inclusive, may be included.
2. The participant has body mass index (BMI) within the range 18 to 40 kilogram per square meter [kg/m^2] (inclusive).
3. The participant has an International Classification of Sleep Disorders, 3rd Edition (ICSD-3) diagnosis of narcolepsy type 1 (NT1) by polysomnography (PSG)/Multiple Sleep Latency Test (MSLT), performed within the past 10 years.
4. The participant is positive for the human leukocyte antigen (HLA) genotype HLA-DQB1*06:02 or results from cerebrospinal fluid (CSF) testing indicate the participant's CSF orexin (OX)/hypocretin-1 concentration is <110 picograms per milliliter ([pg/mL] (or less than one-third of the mean values obtained in normal participants within the same standardized assay).
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Minimum age
16
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with EDS.
2. The participant has medically significant hepatic or thyroid disease.
3. The participant has a history of cancer in the past 5 years (does not apply to participants with carcinoma in situ that has been resolved without further treatment or basal cell cancer).
4. The participant has clinically significant coronary artery disease, a history of myocardial infarction, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure.
5. The participant has a clinically significant history of head injury or head trauma.
6. The participant has history of epilepsy, seizure, or convulsion, or has a family history of inherited disorders associated with seizure (except for a single febrile seizure in childhood).
7. The participant has one or more of the following psychiatric disorders:
1. Any current unstable psychiatric disorder.
2. Current or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including schizoaffective disorder, major depression with psychotic features, bipolar depression with psychotic features, obsessive compulsive disorder, intellectual disability, organic mental disorders, or mental disorders due to a general medical condition as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).
3. Current diagnosis or history of substance use disorder as defined in the DSM-5.
4. Current active major depressive episode (MDE) or who have had an active MDE in the past 6 months.
8. The participant has a history of cerebral ischemia, transient ischemic attack (<5 years ago), intracranial aneurysm, or arteriovenous malformation.
9. The participant has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody/antigen.
10. The participant's renal creatinine clearance (Cockcroft-Gault Equation) is =50 mL/minute.
11. The participant has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values >1.5 times the upper limit of normal (ULN).
12. The participant is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property, or the participant has attempted suicide within the past year.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/01/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
14/12/2023
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Sample size
Target
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Accrual to date
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Final
112
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Woolcock Institute of Medical Research, Sleep and Circadian Research Group - Glebe
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Recruitment postcode(s) [1]
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2037 - Glebe
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Recruitment outside Australia
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United States of America
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Alabama
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United States of America
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California
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United States of America
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Colorado
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Florida
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Georgia
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Kansas
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Massachusetts
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Michigan
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Missouri
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North Carolina
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Ohio
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South Carolina
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Texas
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Virginia
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Finland
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Uusimaa
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France
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Haute-Garonne
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France
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Herault
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France
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Isere
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France
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Paris
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Germany
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Bayern
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Germany
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Mecklenburg-Vorpommern
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Germany
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Berlin
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Germany
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Hamburg
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Italy
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Bologna
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Italy
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Lazio
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Italy
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Molise
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Japan
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Akita
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Japan
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Hukuoka
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Japan
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Kumamoto
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Japan
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Osaka
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Japan
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Tokyo
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Japan
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Nagakute
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Japan
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Yokohama
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Noord-Brabant
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Noord-Holland
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Norway
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Oslo
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Spain
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Alava
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Spain
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Castellon
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Spain
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Valencia
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Spain
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Barcelona
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Spain
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Madrid
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Sweden
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Vastra Gotalands Lan
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Switzerland
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Aargau (de)
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Switzerland
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Ticino (it)
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Switzerland
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Bern
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Takeda
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The main aim of this study is to see how TAK-861 works on symptoms of narcolepsy, including excessive daytime sleepiness and cataplexy. Approximately 100 participants will take part in the study across North America, Europe and Asia Pacific. The treatment (TAK-861 or placebo) will be administered for 8 or 12 weeks. After this treatment period the participant will have the option to participate in a separate, long- term extension study during which all participants will be treated with TAK-861.
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Trial website
https://clinicaltrials.gov/study/NCT05687903
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Study Director
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Address
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Takeda
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
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When will data be available (start and end dates)?
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Available to whom?
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/takeda/
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/03/NCT05687903/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/03/NCT05687903/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT05687903
Download to PDF